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DenTek Instant Pain Relief Maximum Strength

Dosage form: liquid
Ingredients: BENZOCAINE 200mg in 1mL
Labeler: DenTek Oral Care. Inc.
NDC Code: 60630-077

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DenTek Instant Pain Relief

Outer carton labeling

Benzocaine 20%

Oral Pain Reliever

Use for the temporary relief of pain due to: • toothaches  • canker sores  • cold sores  • sore gums

Warnings

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

When using this product  • avoid contact with the eyes  • do not exceed recommended dosage  • do not use for more than 7 days unless directe

Stop use and ask a dentist or doctor if  swelling, rash or fever develops  • irritation, pain or redness persists or worsens  • symptoms do not improve in 7 days  

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Directions  • dip applicator into liquid

Adults and children 2 years of age and older   Apply a small amount of product to the affected area.  Use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years of age   Should be supervised in the use of this product.

Children under 2 years of age   Ask a dentist or doctor.

Other information  • do not use if safety seal on carton is broken  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted  • do not use continuously 

Inactive ingredients:  Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

Questions or comments? Call us  1-800-952-5080 M-F 8am - 5pm EST of visit our website www.dentek.com

inner vial label

DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-077
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
SUCRALOSE 
Product Characteristics
Coloryellow (colorless to light yellow liquid) Score    
ShapeSize
FlavorPEPPERMINT, SPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:60630-077-021 VIAL, GLASS in 1 CARTON
1NDC:60630-077-013.7 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/2014
Labeler - DenTek Oral Care. Inc. (153818646)
Registrant - DenTek Oral Care, Inc. (153818646)

Revised: 11/2013
 
DenTek Oral Care. Inc.

← See all DenTek Instant Pain Relief Maximum Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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